(90 days)
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
The system consists of a pair of glasses coupled with an audio transducer and noise canceling headset. The headset decreases gradient noise by up to 30 dB and includes a microphone that permits two way communication between the technologist and the patient. The video option provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels.
Here's a breakdown of the acceptance criteria and study information based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MRI Compatibility (Safe for use in an MRI environment) | "UCLS Dept of Neurology concludes M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is MRI Compatible and MRI Safe." |
| MRI Safety (Does not pose a hazard or interfere with MRI operation) | "UCLS Dept of Neurology concludes M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is MRI Compatible and MRI Safe." |
| Effective noise reduction (to improve patient comfort) | "The headset decreases gradient noise by up to 30 dB" |
| Ability to provide audio and visual to patients (as intended) | "provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels." |
| Substantial equivalence to predicate device (Avocet Silent Scan, K921891) | Concluded to be substantially equivalent. |
Study Information
The provided document describes a single performance study, primarily focused on MRI compatibility and safety.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Study conducted by UCLS Dept of Neurology."
- Data Provenance: The study was conducted by the UCLA Department of Neurology. It's a prospective study in the sense that the device was evaluated, but the details of the study design (e.g., number of participants, specific tests performed) are not provided. The country of origin is the USA (UCLA).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document only states "Study conducted by UCLS Dept of Neurology concludes..." implying experts from that department made the determination.
- Qualifications of Experts: Not specified beyond being associated with the "UCLS Dept of Neurology."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an accessory to MRI for patient comfort and communication, not an AI-powered diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a hardware device providing audio/visual functionality and noise reduction, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the MRI environment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for MRI compatibility and safety was established by the "UCLS Dept of Neurology." This would typically involve expert assessment against established safety standards for medical devices in an MRI environment, likely through specific testing protocols (e.g., assessing magnetic deflection, heating, image artifact generation, acoustic noise levels). The "30 dB" noise reduction is a direct measurement.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as there is no training set for this type of device.
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Attachment I 510(K) Summary Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system
This 510(K) Summary of safety and effectiveness for the Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Resonance Technology, Inc. |
|---|---|
| Address: | 18121 Parthenia StreetNorthridge, CA 91325 |
| Contact Person: | Mokhtar ZiaratiPresident |
| Telephone: | (818) 882-1997 - Phone(818) 882-5524 - Fax |
| Preparation Date: | December 12, 1999 |
| Device Trade Name: | M.R.Vision 2000 Ultra |
| Common Name:Classification Name: | Accessory to MRISystem, Nuclear Magnetic Resonance ImagingProduct Code: LNH |
| Legally Marketed Predicate Device: | Avocet Silent ScanK number K921891 |
| Description of the M.R. Vision 2000 UltraAudio Visual System / Commander X6System | The system consists of a pair of glasses coupled with anaudio transducer and noise canceling headset. The headsetdecreases gradient noise by up to 30 dB and includes amicrophone that permits two way communication betweenthe technologist and the patient. |
| The video option provides an illusion of viewing a 60" screenand can be viewed in 3D. Television can be viewed with180,000 pixels. | |
| Intended use of the M.R. Vision 2000Ultra Audio Visual System / CommanderX6 System | The . M.R. Vision 2000 Ultra Audio Visual System /Commander X6 System is intended for use in the MRIenvironment to provide audio and visual to patients and thusimprove patient comfort and aid in eliminating fearassociated with MRI use. |
| Performance Data: | Study conducted by UCLS Dept of Neurology concludesM.R. Vision 2000 Ultra Audio Visual System / CommanderX6 System is MRI Compatible and MRI Safe. |
| Conclusion: | The . M.R. Vision 2000 Ultra Audio Visual System /Commander X6 System is substantially equivalent to otherexisting audio visual systems used in the MRI environment incommercial distribution. |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2000
Mokhtar Ziarati President Resonance Technology, Inc. 18121 Parthenia Street Northridge, CA 91325
Re:
K994351 M.R. Vision 2000 Ultra Audio Visual System/ Commander X6 System Dated: December 20, 1999 Received: December 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Ziarati:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual recistration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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INDICATION FOR USE STATEMENT
Pending K 994 351 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System
Indications for Use:
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (per 21 CFR 801.109)
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OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K994351
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.